FDAClass IFebruary 13, 2013

Zicam Extreme Congestion Relief recall: Sterility Concern

Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.

Why was Zicam Extreme Congestion Relief recalled?

Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 2J23, Exp 09/15

Product
Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.
Recalling firm
Matrixx Initiatives Inc
Quantity
46,752 bottles
Distribution
Nationwide.
Recall date
February 13, 2013
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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